Shape changing bone implant and method of use for enhancing healing

ABSTRACT

Described is a new bone healing method and class of bone fixation implants that change shape once implanted so as to minimize non-healing and speed the bone healing process. The bone fixation method involves shape changing implants that continuously hold the bones in apposition so that a gap does not form. Gaps in time allow non-bony tissue to infiltrate and stop healing. Furthermore, the implants actively compress bone to increase bone mass and strength. Bone cell pressure due to compression and electrical current flow due to bone deformation act to stimulate healing. The new implant designs also provide a scaffolding to conduct bone through the implant and across the healing bone interface. The methods and designs are applicable to but not limited to use for bone screws, plates, staples, rods, cylinders and external fixation devices.

RELATED PATENT APPLICATIONS

This Application a reissue application of U.S. Pat. No. 10,448,979,entitled “Shape Changing Bone Implant And Method Of Use For EnhancingHealing,” which issued on Oct. 22, 2019, from U.S. patent applicationSer. No. 14/351,032, filed Apr. 10, 2014, which is the 35 U.S.C. § 371national application of International Patent Application No.PCT/US2012/059603, entitled “Shape Changing Bone Implant And Method OfUse For Enhancing Same,” filed Oct. 10, 2012, which designated theUnited States and claimed priority to U.S. Patent Appl. Ser. No.61/545,391, entitled “Bone Healing Devices and Methods For Making andUsing Thereof,” filed on Oct. 10, 2011. Both of these These patentapplications are commonly owned by the owner of the present invention.

This Application is related to: (a) U.S. patent application Ser. No.13/192,162; (b) U.S. patent application Ser. No. 13/192,177; (c) U.S.patent application Ser. No. 13/192,186; and (d) U.S. patent applicationSer. No. 13/192,198. Each of the foregoing patent applications werefiled on Jul. 27, 2011, are entitled “Bone Staple, Instrument and Methodof Use And Manufacturing,” and are commonly owned by the owner of thepresent invention.

This Application is also related to International Patent Appl. No.PCT/US2012/048539, entitled “Bone Staple, Instrument and Method of UseAnd Manufacturing,” filed on Jul. 27, 2012, and is commonly owned by theowner of the present invention.

The foregoing patent applications are hereby incorporated herein byreference in their entirety for all purposes.

TECHNICAL FIELD

This application relates to promoting bone healing with a new class ofshape changing bone implants used for fixation of the musculoskeletalsystem. Bone healing is promoted because the implants change shape toconstantly hold the healing interface of bone segments in appositionwhile compressing. The implants change shape through their metallurgic(or polymeric) properties and mechanisms to use mechanically storedstrain energy pull together and compresses bone to induced an enhancedhealing response. These implants can also act as a scaffolding for bonethus conducting bone formation through the implant during the healingprocess.

BACKGROUND

Bone wires, screws, staples, rods, plates, and combinations of thesedevices have been in clinical use for decades. These bone fixationdevices have evolved from industrial designs for fastening wood, steel,plastic or other materials. The use of these types of devices for bonefixation and the formation of a rigid construct of bone and implant arethe basis of current skeletal fixation technology to support healing andfunctional repair.

In spite of this prior art rigid internal fixation implant technology,bone healing and repair often does not occur. In these circumstances,fractures may not heal and bone cuts or diseased joints may not fuse.This delayed- or non-healing response occurs because the bones are toofar apart, unwanted motion occurs, soft tissue fills the space betweenthe healing bones, or the biologic response to healing is poor (whichcan be due to a host of factors, including age, systemic disease,infection, diet, or smoking).

Rigid bone implants are commonly hammered, wedged, screwed, or fixedwith wire into bone. Surgical techniques involve alignment of the bonesegments, approximating the edges where healing should occur, and usingimplants to rigidly hold the bones in place.

The first phase of bone healing is inflammation. This normal responserecruits cells into the wound to remove debris including necrotictissue. In this process the bone edges that were surgically approximatedare broken down by tissue digesting cells causing gaps between the boneedges to form. These gaps, caused by difficult surgical reduction and/orinflammation mediated bone resorbtion, delay healing because more bonetissue must form to fill the gaps and bone healing may stop if softtissue infiltrates the gaps and impedes or blocks bone fusion.

Until recently, all known implants were rigid constructs. Nitinol bonestaples described in patents/patent applications of the Applicant (Fox'677 Patent, Fox '808 Application, Fox '506 Application), as well asother related patents (Jervis '957 Patent, Mai '443 Patent, Mai '557Patent, Groiso '359 Patent, Groiso '414 Patent, Groiso '367 Patent,Bertolet '707 Patent, Allen '787 Patent, Allen '054 Patent, Allen '531Patent, Flot '805 Patent, Flot '461 Patent, Ogilvie '805 Patent) alongwith non-nitinol staples (Mohr '828 Patent), were the first bonefixation implants that changed or were caused to change shape to fastenbone.

Some of these devices are presently on the market such as thoseillustrated in BioMedical Enterprises's Product Sell Sheet. Othercompanies, such as MBA (France), used the technology described andtaught in Flot '589 Patent and Flot '461 Patent, which used electricalcurrent to heat the staple. These two commercial technologies causedthese nitinol staples to change shape when heated but had little, anddepending on implantation technique, often no continued shape changewhen healing.

Memometal, Inc.'s (now Stryker Corp. (Kalamazoo, Mich.)) EasyClip™staples and BioMedical Enterprises, Inc.'s Speed™ staples are nitinolstaples that spring back but use a non-contracting straight bridge andconsequently can not pull the two bone segments any closer together thanthe spacing of the original two drill holes.

Biopro's Memory Staple Brochure and Depuy's Memory Staple Brochure bothshow a nitinol staple that changes shape at body temperature hoursfollowing the operative procedure. These staples are changing shape whenimplanted so are inconsistently implanted. They create bone fixationforce when the wound is closed, sometimes creating complications, suchas fracture or malalignment.

Other devices, such as the FxDevices' Pogo® screw described in Tipirneni'026 Application, Tipirneni '248 Application, and Tipirneni '127Application, US2007/0162026 and FDA K080649 Clearance to Market Letter,use internal features such as moving parts and springs to createcompression. Patents to which the Applicant is the inventor (Fox '351Patent, Fox '310 Patent) also include internal mechanisms to change theshape of the implant to conform to the bone defect into which they areplaced. These devices provide bone compression at the edges of a hole,and, in the experimental use of implants fabricated using the technologyof Fox '351 Patent and Fox '310 Patent, they were shown to cause thebone being compressed by the implant to become more dense in structureand presumably stronger.

Though Fox '351 Patent and Fox '310 Patent is the first work known tothe Applicant of an implant compressing bone that results in increasesin bone density. Historically the research literature on the effects ofthe mechanical loading of intact bone is well known and referred to asWolff's Law. Wolff's law is a theory developed by Julius Wolff(1836-1902) that states that bone in a healthy person will adapt to theloads it is placed under. If loading on a bone increases, that bone willremodel itself over time to become stronger to resist that the loading.Conversely, if the loading on the bone decreases, it will become weakeras there is no stimulus for the continued remodeling (which is requiredto maintain bone mass).

Wolff's Law has resulted in a clinical recommendation to exercise todelay osteoporosis or bone loss in the weightlessness of outer space.Like muscle, exercise that mechanically loads bone also seems toincrease the bone size and strength. This phenomena associated withWolff's Law is known as mechanotransduction.

Studies of mechanotransduction are replete in the literature involvingspace flight, bed rest, functional loading and remodeling, and have beenpublished by many, including, but not limited to: Chama 1972, Chama1972, Turner 1993, Robling 2006, Warden 2004, and Rubin 1985. However,no theory or understanding has been presented on the enhancement of bonehealing with implants that change shape to pull together and compressthe healing bone interface.

Chamay 1972 reported about compression induced microlesions and a boneformation and hypertrophy response in three different test groups. Theystudied three loading conditions: (1) a dynamic fatigue test group, (2)a static overload group, and (3) single load group, and showed that eachresulted in various degrees, locations, and timing of new boneformation.

Chao 2003 stated that, though it has long been hypothesized that thatthere is a link between mechanical stimulation and fracture healing, thebiologic pathways and regulating cellular mechanisms remain unknown.Chao 2003 further stated that when the mechanisms at the cellular levelsbecame understood, physiological conditions or pharmacological agentsmay be developed to enhance bone healing.

These studies of mechanotransduction have been focused on the remodelingof intact bone to impede osteoporosis and though effects on bonefracture healing have been hypothized no method, device, substance, orresearch has been proposed to enhance fracture healing.

SUMMARY OF THE INVENTION

The embodiments of the subject invention describe an improved boneimplant that stores recoverable mechanical energy in its structure ormechanism and changes shape to pull together and compress the bonefixation interface. This is a new class of implant that not onlycompresses but can translate bone segments to hold them into constantapposition which has multiple advantages over prior bone fixationdevices that are rigid. This invention further describes a method ofmanipulating bone to promote healing and minimize non-healing events byholding the bone edges in constant contact and applying pressure to thehealing interface to promote a biologic response to form bone. Thismethod is further enhanced by implants that can act as a scaffolding forbone, thus conducting bone formation through the implant so as to fusethe bone segments.

In general, in one aspect, the invention features a bone healing methodthat includes selecting a bone implant operable for pulling together afirst bone segment and a second bone segment and operable forcompressing the first bone segment and the second bone segment at a bonehealing interface. The method further includes positioning the boneimplant in a position to pull the first bone segment and the second bonesegment together and to compress the first bone segment and the secondbone segment at the bone healing interface. During the step ofpositioning in the method, the bone implant applies no mechanical forceto pull the first bone segment and the second bone segment together.During the step of positioning in the method, the bone implant appliesno mechanical force to compress the first bone segment and the secondbone segment at the bone healing interface. The method further comprisesthat, after positioning of the bone implant, mechanically activating thebone implant. The mechanically activated bone implant pulls together thefirst segment and the second bone segment. The mechanically activatedbone implant compresses the first bone segment and the second bonesegment at the bone healing interface. The mechanically activated boneimplant maintains the first bone segment and the second bone segment atthe bone healing interface while the first bone segment and the secondbone segment heal.

Implementations of the invention can include one or more of thefollowing features:

The bone implant can be a cage, wire, staple, plate, screw, rod, tubularstructure, external fixation device, or a combination thereof.

The bone implant can have a first shape. The first shape can be anexpanded shape. The bone implant can be in the first shape during thestep of positioning.

The bone implant can have a second shape. The second shape can be acontracted shape. The bone implant can move from the first shape towardthe second shape during or after the step of mechanically activating thebone implant.

The bone implant can have a first shape change in first direction and asecond shape change in another direction. The first shape change and thesecond shape change can be different. The first shape change can be ashape expansion or contraction. The second shape change can be a shapeexpansion or contraction.

The bone implant can change to a different shape during or after thestep of mechanically activating the bone implant.

The transition of the bone implant to the different shape can beoperable for pulling together the first bone segment and the second bonesegment. The transition of the bone implant to the different shape canbe operable for compressing the first bone segment and the second bonesegment at the bone healing interface.

The bone implant can include nitinol.

The bone implant can include an activator. Before the activator isremoved from the bone implant, the activator can retain the bone implantin a first shape in which at least some of the nitinol in the boneimplant is in the form of stress induced or retained martensite. Theactivator can be removed from the bone implant during the step ofmechanically activated bone implant. After the activator is removed fromthe bone implant, the bone implant can change shape, during which atleast some of the nitinol in the bone implant can change in form toaustenite.

The bone healing implant can include a shape memory metal, an elasticbiocompatible metal, an elastic biocompatible polymer, or a combinationthereof.

The bone healing implant can include stainless steel, titanium, or acombination thereof.

The bone healing implant can include comprises polyether ether ketone(PEEK), polyethylene, or a combination thereof.

The bone implant can include a spring. The spring can be released duringthe step of mechanical activating the bone implant. The spring canprovide the mechanical force that pulls together the first bone segmentand the second bone segment. The spring can provide the mechanical forcethat compresses the first bone segment and a second bone segment at thebone healing interface. The spring can provide the mechanical force thatmaintains the bone under compression while the bone heals.

The bone implant can include nitinol. Before the spring is released, thespring can hold the bone implant in a shape in which at least some ofthe nitinol in the bone implant is in the form of martensite. The boneimplant can hold together the first bone segment and the second bonesegment such that soft tissue infiltration is blocked.

The bone implant can deform the first bone segment and the second bonesegment so as to create an electrical current flow in the first bonesegment and the second bone segment.

The bone implant can include a shape changing cage.

The shape changing cage can include at least one bone conductingscaffold feature.

The shape changing cage can include a first component, a secondcomponent, and a spring.

During the step of mechanical activation of the method, a locking pincan be removed from the bone implant. During the step of mechanicalactivation of the method, the first component and the second componentcan be pulled together. The pulling together of the first component andthe second component can pulls together the first bone segment and thesecond bone segment. The pulling together of the first component and thesecond component can compress. the first bone segment and the secondbone segment at the bone healing interface. The pulling together of thefirst component and the second component can maintain the first bonesegment and the second bone segment at the bone healing interface whilethe first bone segment and the second bone segment heal.

The shape changing cage can include nitinol.

The shape changing cage can include a shape memory metal, an elasticbiocompatible metal, an elastic biocompatible polymer, or a combinationthereof.

The shape changing cage can include stainless steel, titanium, or acombination thereof.

The shape changing cage can include polyether ether ketone (PEEK),polyethylene, or a combination thereof.

The shape changing cage can include a first cylindrical component and asecond cylindrical component. The first cylindrical component and secondcylindrical component can be locked in place to prevent them from movingtogether.

The bone implant can further include a mandrel that locks the shapechanging cage in a first shape.

The mandrel can include a bone cutting insertion tip that is used duringthe step of positioning the bone implant.

The step of mechanically activating the bone implant in the method caninclude unlocking the cage by removing the mandrel from the implant.Unlocking the cage can allow the cage to change its shape. The change inshape of the cage can pull together the first segment and the secondbone segment. The change in shape of the cage can compress the firstbone segment and the second bone segment at the bone healing interface.The change in shape of the cage can maintain the first bone segment andthe second bone segment at the bone healing interface while the firstbone segment and the second bone segment heal.

The shape changing cage can include nitinol.

The shape changing cage can include a shape memory metal, an elasticbiocompatible metal, an elastic biocompatible polymer, or a combinationthereof.

The shape changing cage can include stainless steel, titanium, or acombination thereof.

The shape changing cage can include polyether ether ketone (PEEK),polyethylene, or a combination thereof.

In general, in another aspect, the invention features a bone implantthat includes a biocompatible material structure that is in a firstshape. The first shape allows the section to be positioned proximate toa first bone segment and a second bone segment without the biocompatiblematerial structure applying mechanical forces to pull together the firstbone segment and the second bone segment. The first shape allows thesection to be positioned proximate to a first bone segment and a secondbone segment without the biocompatible material structure applyingmechanical forces to compress the first bone segment and the second bonesegment at a bone healing interface. The bone implant further includesan actuator holding the biocompatible material structure in the firstshape. The biocompatible material structure is operable to move toward asecond shape upon actuation of the actuator. The movement of thebiocompatible material structure toward the second shape is operable topull together the first segment and the second bone segment. Themovement of the biocompatible material structure toward the second shapeis operable to compress the first bone segment and the second bonesegment at the bone healing interface. The movement of the biocompatiblematerial structure to the second shape is operable to maintain the firstbone segment and the second bone segment at the bone healing interfacewhile the first bone segment and the second bone segment heal.

Implementations of the invention can include one or more of thefollowing features:

The biocompatible material structure can include at least one boneconducting scaffold feature.

The biocompatible material structure can be a cage, wire, staple, plate,screw, rod, tubular structure, external fixation device, or acombination thereof.

The first shape can be an expanded shape.

The second shape can be a contracted shape.

The first shape can be a contracted shape.

The second shape can be an expanded shape.

The biocompatible material structure can include nitinol.

At least some of the nitinol in the biocompatible material structure canbe in the form of stress induced or retained martensite when thebiocompatible material structure is in the first shape. At least some ofthe nitinol can be operable for changing in form from martensite toaustenite due to change in the biocompatible material structure from thefirst shape toward the second shape.

The bone healing implant can include a shape memory metal, an elasticbiocompatible metal, an elastic biocompatible polymer, or a combinationthereof.

The bone healing implant can include stainless steel, titanium, or acombination thereof.

The bone healing implant can include polyether ether ketone (PEEK),polyethylene, or a combination thereof.

The bone implant can further include a spring. The spring can beoperatively connected to the biocompatible material structure and theactuator such that actuation of the actuator is operable for releasingof the spring. The spring can be operatively connected to thebiocompatible material structure and the actuator such that releasing ofthe spring is operable for releasing the biocompatible materialstructure such that the biocompatible material structure can change fromthe first shape toward the second shape.

The biocompatible material structure can include nitinol.

The biocompatible material structure can include a shape memory metal,an elastic biocompatible metal, an elastic biocompatible polymer, or acombination thereof.

The shape changing cage can include stainless steel, titanium, or acombination thereof.

The shape changing cage can include polyether ether ketone (PEEK),polyethylene, or a combination thereof.

The movement of the biocompatible material structure toward the secondshape can be operable to compress the first bone segment and the secondbone segment at the bone healing interface to block soft tissueinfiltration.

The movement of the biocompatible material structure toward the secondshape can be operable to deform the first bone segment and the secondbone segment so as to create an electrical current flow in the firstbone segment and the second bone segment.

The biocompatible material structure can include a shape changing cage.

The shape changing cage can include at least one bone conductingscaffold feature.

The shape changing cage can include a first component and a secondcomponent. The bone implant can further include a spring. The spring canbe operable to maintain the first component and the second component sothat the shape changing cage is in the first shape. The spring can beoperable to be released by the actuation of the actuator. The firstcomponent and the second component can be operable to pull together,upon release of the spring, to move the shape changing cage toward thesecond shape.

The activator can be a plate, tong, clip, wire, rod, or a combinationthereof.

The activator can be a locking pin.

The first component and the second component can be operable for pullingtogether when the locking pin is removed from the bone implant. Thepulling together of the first component and the second component can beoperable for pulling together the first bone segment and the second bonesegment. The pulling together of the first component and the secondcomponent can be operable for compressing the first bone segment and thesecond bone segment at the bone healing interface. The pulling togetherof the first component and the second component can be operable formaintaining the first bone segment and the second bone segment at thebone healing interface while the first bone segment and the second bonesegment heal.

The biocompatible material structure can include nitinol.

The biocompatible material structure can include a shape memory metal,an elastic biocompatible metal, an elastic biocompatible polymer, or acombination thereof.

The biocompatible material structure can include stainless steel,titanium, or a combination thereof.

The biocompatible material structure can include polyether ether ketone(PEEK), polyethylene, or a combination thereof.

The shape changing cage can include a first component and a secondcomponent. The first component and the second component can be locked inplace by the actuator. The first component and the second component canbe operable for pulling toward each other upon actuation of theactuator.

The actuator can be a mandrel that locks the cage in the first shape.

The mandrel can include a bone cutting insertion tip.

The actuator can be operable for removal from the shape changing cage toallow the shape changing cage to change its shape from the firstposition toward the second position.

The shape changing cage can include nitinol.

The shape changing cage can include a shape memory metal, an elasticbiocompatible metal, an elastic biocompatible polymer, or a combinationthereof.

The shape changing cage can include stainless steel, titanium, or acombination thereof.

The shape changing cage can include polyether ether ketone (PEEK),polyethylene, or a combinations thereof.

In general, in another aspect, the invention features a bone healingimplant that includes a shape changing washer and a threaded bone screw.The shape changing washer and the threaded bone screw are operable foruse to pull together a first bone segment and a segment bone segment.The shape changing washer is operable for storing mechanical energy bychanging its shape as the threaded bone screw is rotated when used topull together the first bone segment and the segment bone segment. Thestored mechanical energy of the shape changing washer is operable topull together the first bone segment and a second bone segment. Thestored mechanical energy of the shape changing washer is operable tocompress the first bone segment and the second bone segment at the bonehealing interface. The movement of the biocompatible material structureto the second shape is operable to maintain the first bone segment andthe second bone segment at the bone healing interface while the firstbone segment and the second bone segment heal.

Implementations of the invention can include one or more of thefollowing features:

The shape changing washer can have changing bellows.

The bone healing implant can further include at least one boneconducting scaffold feature.

The shape changing washer can include nitinol.

The shape changing washer can include a shape memory metal, an elasticbiocompatible metal, an elastic biocompatible polymer, or a combinationthereof.

The shape changing washer can include stainless steel, titanium, or acombination thereof.

The shape changing washer can include polyether ether ketone (PEEK),polyethylene, or combination thereof.

In general, in another aspect, the invention features a bone healingmethod that includes selecting a bone implant. The bone implant has atleast one bone scaffold feature. The method further includes positioningthe bone implant in a position to pull first bone segment and a secondbone segment together and to compress the first bone segment and thesecond bone segment at the bone healing interface. When so positioned inthe method, the bone implant pulls together the first segment and thesecond bone segment. When so positioned in the method, the bone implantcompresses the first bone segment and the second bone segment at thebone healing interface. When so positioned in the method, the boneimplant maintains the first bone segment and the second bone segment atthe bone healing interface while the first bone segment and the secondbone segment heal. The bone scaffold feature conducts bone through thebone implant and across the healing bone interface utilizes while thefirst bone segment and the second bone segment heal.

Implementations of the invention can include one or more of thefollowing features:

The bone scaffold feature can be a fenestration for bone ingrowth.

The bone scaffold feature can be a circular fenestration for boneingrowth, an elongated fenestration for bone growth, a slot fenestrationfor bone growth, a lumen for bone ingrowth, or a combination thereof.

The bone scaffold feature can be a shape changing feature.

The bone implant can include nitinol.

The bone implant can include a shape memory metal, an elasticbiocompatible metal, an elastic biocompatible polymer, or a combinationthereof.

The bone implant can include stainless steel, titanium, or a combinationthereof.

The bone implant can include polyether ether ketone (PEEK),polyethylene, or a combination thereof.

In general, in another aspect, the invention features a bone implantthat includes biocompatible material structure that is in a first shape.The first shape allows the biocompatible material structure to bepositioned proximate to a first bone segment and a second bone segment.The biocompatible material structure is operable to move from a firstshape to a second shape. Movement of the biocompatible materialstructure toward the second shape is operable to pull together the firstsegment and the second bone segment. Movement of the biocompatiblematerial structure toward the second shape is operable to compress thefirst bone segment and the second bone segment at the bone healinginterface. Movement of the biocompatible material structure to thesecond shape is operable to maintain the first bone segment and thesecond bone segment at the bone healing interface while the first bonesegment and the second bone segment heal. The bone implant furtherincludes at least one bone scaffold feature incorporated with thebiocompatible material structure. The bone scaffold feature is operableto conduct bone through the implant and across the healing boneinterface while the first bone segment and second bone segment heal.

Implementations of the invention can include one or more of thefollowing features:

The bone scaffold feature can be a fenestration for bone ingrowth.

The bone scaffold feature can be a circular fenestration for boneingrowth, an elongated fenestration for bone growth, a slot fenestrationfor bone growth, a lumen for bone ingrowth, or a combination thereof.

The bone scaffold feature can be a shape changing feature.

The biocompatible material structure can include nitinol.

The biocompatible material structure can include a shape memory metal,an elastic biocompatible metal, an elastic biocompatible polymer, or acombination thereof.

The biocompatible material structure can include stainless steel,titanium, or a combination thereof.

The biocompatible material structure can include polyether ether ketone(PEEK), polyethylene, or a combination thereof.

There has thus been outlined, rather broadly, the more importantfeatures of the invention in order that the detailed description thereofmay be better understood, and in order that the present contribution tothe art may be better appreciated. There are additional features of theinvention that will be described hereinafter.

In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in its application to the details of construction and to thearrangements of the components set forth in the following description orillustrated in the drawings. The invention is capable of otherembodiments and of being practiced and carried out in various ways.Also, it is to be understood that the phraseology and terminologyemployed herein are for the purpose of the description and should not beregarded as limiting.

DESCRIPTION OF DRAWINGS

FIG. 1 illustrates a rigid bone fixation plate and screw system of theprior art.

FIG. 2 illustrates the rigid bone fixation plate and screw system ofFIG. 1 holding the bone segments apart.

FIG. 3 illustrates a shape changing bone plate with displacement sectionextended, unstable, and able to pull together and compress bone segmentsso as to close the gap and compress the bone segments at the healinginterfaces.

FIG. 4 illustrates the shape changing bone plate with displacementsection of FIG. 3 contracted to hold the gap closed and compress thebone segments.

FIG. 5 illustrates a shape changing bone staple with the bridgeextended, legs straightened, and mechanically unstable so that itsspontaneous shape change closes the gap.

FIG. 6 illustrates the shape changing bone staple of FIG. 5 with thebridge contracted and legs deflected inward to hold the gap closed andcompress the bone segments.

FIG. 7 illustrate a shape changing cylindrical fenestrated hollow cage,in its extended length, contracted diameter and unstable state, whichuses an internal spring to close the gap and compress the boneinterfaces.

FIG. 8 illustrates the shape changing cylindrical fenestrated hollowcage of FIG. 7 in its contracted length and expanded diameter using theinternal spring's strain energy to expand the cage diameter, lock intothe central lumen of bone and shorten the cage's length so as to closedand compress the gap between bone segment and interfaces.

FIG. 9 illustrates an orthogonal view of the bone fixation cylindricalcage of FIG. 7 with lock pin in its elongated and diametricallycontracted pre-implantation condition with maximum stored mechanicalstrain energy.

FIG. 10 illustrates an orthogonal view of the bone fixation cylindricalcage of FIG. 8 in its shortened and expanded post-implantation conditionwith no stored mechanical strain energy.

FIG. 11 illustrates a plane view of a bone fixation cylindrical cage ofthe bone fixation cylindrical cage of FIG. 8 in its shortened andexpanded post-implantation condition with no stored mechanical strainenergy showing bone locking members, bone in growth fenestrations,circular fenestrations, and lock pin receiver.

FIG. 12 illustrates an orthogonal view of the components of the bonefixation cylindrical cage of FIGS. 7-8 that is disassembled to show thetwo cylindrical components and spring.

FIG. 13 illustrates a shape changing cylindrical fenestrated hollow cagein its extended length, contracted diameter, and unstable state thatuses its elastic material properties to close the gap and compress thebone interfaces.

FIG. 14 illustrates the shape changing cylindrical fenestrated hollowcylinder of FIG. 13 in its contracted length and expanded diameter usingits material properties to pull the gap closed and compress the boneinterfaces.

FIG. 15 illustrates an orthogonal view of a bone fixation cylindricalcage of FIG. 13 in its elongated and diametrically contractedpre-implantation condition with bone ingrowth fenestrations and holes,and elongated ribs storing maximum mechanical strain energy.

FIG. 16 illustrates an orthogonal view of the bone fixation cylindricalcage of FIG. 14 in its shortened and expanded post-implantationcondition with bulging ribs and no stored mechanical strain energy.

FIG. 17 illustrates an orthogonal view of the bone fixation cylindricalcage of FIG. 13 in its extended and diametrically contractedpre-implantation state while locked on an implantation mandrel having abone cutting insertion tip, with the mandrel lobe engaged in cageinstrument fenestration and the driver fenestrations accessible tofacilitate release.

FIG. 18 illustrates an orthogonal view of the bone fixation cylindricalcage of FIG. 14 in its shortened and expanded post-implantationconfiguration following release from the implantation mandrel throughrelease of the mandrel lobe and cage instrument release fenestration.

FIG. 19 illustrates a shape changing washer it its unstable state that,using the material's elastic properties, pulls on a bone screw to pulltogether bone segments to close the gap.

FIG. 20 illustrates the changing washer of FIG. 19 that, using thematerial's elastic properties, deflects its structure to pull on a bonescrew to pull together bone segments, hold the gap closed, and compressthe bone segments at the healing interface. FIG. 21 illustrates athreaded bone screw with mechanical energy storing shape changing washerof fully strained and storing maximum energy.

FIG. 22 illustrates the threaded bone screw and mechanical energy shapechanging washer of FIG. 21 with the mechanical energy storing shapechanging washer partially strained and storing an intermediate amount ofenergy.

FIG. 23 illustrates the threaded bone screw and mechanical energystoring shape changing washer of FIG. 21 with the mechanical energystoring shape changing washer fully recovered in its shape and storingno energy.

FIG. 24 illustrates an orthogonal view of an alternate embodiment of ashape changing washer that can be used with a threaded bone screw,showing the shape changing washer fully recovered in its shape changingbellows section and storing no energy.

FIG. 25 illustrates an orthogonal view of the alternate embodiment ofthe shape changing washer of FIG. 24 showing the shape changing washerfully extended in its shape changing bellows section and storing maximumenergy.

REFERENCE NUMERALS

-   -   10 First bone segment.    -   20 Second bone segment.    -   30 Rigid bone plate.    -   40 Rigid bone plate screws.    -   50 Bone healing junction between the first bone segment and        second bone segment being held in contact.    -   60 Inflammation, motion or procedure induced bone gap with        non-bony tissue interpositioned between the first bone segment        and second bone segment.    -   62 Bone healing interface of second bone segment 20.    -   64 Bone healing interface of first bone segment 10.    -   70 Shape changing element of a contracting bone plate 90 in its        unstable uncontracted state.    -   80 Shape changing element of a contracting bone plate 90 in its        contracted state.    -   90 Shape changing bone plate that can exist in a contracted,        extended or intermediate state.    -   100 Shape changing staple in its unstable uncontracted state in        which it stores mechanical energy and is in a condition to pull        together and compress the bone segments 10 and 20 so as to        continuously close the gap 60.    -   110 Shape changing bone staple in its contracted state in which        its bridge has shortened and its legs have deflected inwards.    -   120 Shape changing cylindrical fenestrated hollow cylinder in        its extended length and contracted diameter with internal        springs.    -   130 Shape changing cylindrical fenestrated hollow cylinder in        its contracted length and expanded diameter.    -   140 Shape changing cylindrical fenestrated hollow cage in its        extended length and contracted diameter unstable state that uses        its material properties to change shape.    -   150 Shape changing cylindrical fenestrated hollow cylinder in        its contracted length and expanded diameter using its material        properties to change shape.    -   153 Cage implantation mandrel for a shape changing cylindrical        fenestrated hollow cylinder.    -   155 Cage implantation mandrel retention lobe.    -   156 Bone cutting insertion tip of insertion mandrel 153.    -   160 Bone screw configured to operate with a shape changing        washer.    -   170 Shape changing washer in its unstable state ready to change        shape with maximum stored elastic energy.    -   180 Shape changing washer in a partially deflected state pulling        on the bone screw    -   160 and compressing bone as the interface gap 50 is held in        apposition.    -   185 Shape changing washer with no stored elastic energy.    -   190 Movably connected expansion member for cylindrical        fenestrated cylindrical cage.    -   200 Circular fenestrations for bone ingrowth.    -   210 Elongated fenestrations for bone ingrowth.    -   220 Mechanical energy storage and shape change spring.    -   230 Movably connected expansion member actuator.    -   240 Shape changing cylindrical internal locking fenestration.    -   250 Fenestration mechanism lock pin.    -   260 Lock pin manipulator.    -   270 Lock pin receiver.    -   280 First half of shape changing cylindrical cage.    -   290 Second half of shape changing cylindrical cage.    -   400 Alternate embodiment of a shape changing washer.    -   410 Alternate embodiment washer 400 with shape changing section        elongated and storing mechanical elastic strain energy.    -   420 Alternate embodiment washer 400 with shape changing section        contracted and not storing mechanical elastic strain energy.    -   510 Circular fenestrations of the alternate embodiment for bone        ingrowth.    -   520 Slot fenestrations of the alternate embodiment for bone        ingrowth.    -   530 Expanded ribs of the fenestrated cylinder.    -   540 Instrument driving fenestrations.    -   550 Instrument release fenestrations.    -   560 Shape changing bone fixation cylinder lumen for bone        ingrowth.    -   570 Straight ribs of the fenestrated cylinder storing maximum        shape changing energy.

DETAILED DESCRIPTION

The invention consist of a method of enhancing bone healing by activelypulling the bone segments together at the healing interface andsqueezing so as to continuously hold the bones in contact and createmechanical stress in the bone. The invention further includes bonefixation implants that change shape to implement this method. Theenhanced bone healing due to mechanical shape change is further advancedthrough embodiments of the implant invention that conduct bone healingthrough fenestrations and its lumen. Bone fixation shape changingimplant designs that use this method include screws, washers,cylindrical cages, plates, staples, rods, and external fixators.

Since around 2000, Applicant has observed surgical procedures and thebone healing outcome when the OSStaple™ implant (Applicant's inventiondisclosed and taught in Fox '677 Patent) was implanted to fixate bonefracture and fusions. In such observations by Applicant (and confirmedby direct discussions with clinicians performing the proceduresobserved), unexpected results were observed and it was seen that (1) theOSStaple™ implant changed shape in bone with time, (2) the bone cut“osteotomy” or fracture was not visible on x-ray at an earliertime-point in healing, (3) the bone healed through primary bone healing(i.e., without a callus and just direct fusion with normal anatomy), notsecondary bone healing (i.e., with a callus and bulbous anatomy at thefusion site), (4) that healing occurred quicker, and (5) non-healingoccurred less frequently.

These remarkable observations were unexpected and upon further study twoconditions were observed that illustrated the mechanism through whichhealing was enhanced. One mechanism was that the implant's shape changeclosed bony gaps, which mechanically blocked soft tissue infiltrationbetween the bone segments. A second mechanism was that the implant'smechanical loading of bone played to Wolff's Law and stimulated bone toheal with greater bone density and size. This second mechanism affectedboth bone cell and bone matrix.

Bone is composed of collagen and calcium phosphate. The calciumphosphate forms crystalline hydroxyapatite. When the bone matrix isstrained, the crystalline hydroxyapatite is strained and through itspiezoelectric properties creates current flow. Electrical current flowhas been reported in bone when strained. Electronic bone healingstimulators that place electrodes in the bony wound or pulseelectromagnetic fields through bone report that their mechanism ofhealing is cell recruitment driven due to the induced current flow inbone. This mechanical strain induced current flow is one of twomechanisms of enhanced bone healing activated with the implants that usethis method of enhanced healing.

The second of two mechanisms is the effect of compression and increasedenvironmental pressure on the bone forming cells within the compressionregion. Bone cells in intact healthy bone have been shown to respond tomechanical loading to build more and stronger bone. Applicant'sunexpected observation is that this response occurred in healing bone,which is a much different process than the remodeling that strengthensintact healthy bone. Bone healing includes inflammation, boneresorbtion, non-mineralized matrix formation, and mineralization of thematrix. Remodeling of intact bone does not include all of theseprocesses. Implants designed to change shape to pull together andcompress a healing bone fracture, cut or fusion is a significant advancein skeletal healthcare.

In general, the bone healing method and devices that change shape andpull together and compress bone can be applied throughout the skeletalsystem. For example, the invention can be an implant device for healingof fingers and toe bones. The method and devices provide the clinicianthe ability to implant the devices in their proper position and thenrelease the device so that it can have the mechanical energy to (a)compress the bone segments, and (b) maintain the compression during thebone healing process. Accordingly, the devices have an activator thatcan be withdrawn from the device (such as, for example, a rod that canbe withdrawn allowing a spring to provide the mechanical energy) or canremain with the device (such as, for example, a screw that can berotated to allow a spring to provide the mechanical energy). Because thebone healing device is not activated until after it is in place, thisallows the clinician to fully position it before activation. Moreover,when the device is not properly positioned, the bone healing device canbe removed by the clinician before activation and then correctlypositioned.

Furthermore, the implants can act as a scaffolding for bone thusconducting bone formation through the implant. This further facilitatesthe healing of bone segments.

The embodiments of the present inventions thus overcome the deficienciesof the prior rigid bone fixation implants, such as (1) not closing a gapformed at the edges of the fracture or cut due to inflammation, (2)holding the bone ends at a distance that is too far for bone cells tobridge to facilitate healing, (3) holding the bone so that compressionloads in bone do not occur, (4) holding a gap between the ends of boneso that soft tissue can infiltrate into the gap and delay or preventhealing, (5) not mechanically straining bone to illicit piezoelectriccurrent flow, (6) not mechanically straining or modulating bone cellpressure to stimulate these cells to form and model bone, (7) providinga scaffolding to conduct bone to grow through the implant and (8) othersdeficiencies that will become more clear in the review of theembodiments of the subject invention.

Moreover, the implants allow the clinician the ability to implant thedevices in their proper position and then activate them. Thiscombination significantly eases the burdens on the clinicians when usingimplants. Moreover, by doing so, this increases the clinicians' abilityto properly place the implants. Proper placement is additionallybeneficial as the implants can be utilized for scaffolding for bonegrowth.

In embodiments of the invention, the implant can include a shape memorymetal (such as nitinol), which can utilize the pseudo elastic propertiesof such materials. Alternatively, the implant can be made of any elasticbiocompatible metal (such as stainless steel, titanium, etc.) or can bemade of an elastic biocompatible polymer (such as polyether ether ketone(PEEK),), polyethylene, etc.).

FIGS. 1-4 are illustrative of how the present invention overcome thedeficiencies of the prior rigid bone fixation implants. FIG. 1illustrates a rigid bone fixation plate and screw system of the priorart. This system includes a rigid bone plate 30 and rigid bone platescrews 40. As illustrated in FIG. 1 , this system is utilized to hold incontact a first bone segment 10 and a second bone segment 20 at the bonehealing junction 50 between these two bone segments.

FIG. 2 illustrates the rigid bone fixation plate and screw system ofFIG. 1 holding first bone segment 10 and second bone segment 20 apartafter formation of an inflammation, motion or procedure induced gap 60between the bone healing interface 62 (of second bone segment 20) andbone healing interface 64 (of first bone segment 10).

In embodiments of the present invention shown in FIGS. 3-4 , a shapechanging plate 90 utilizes a shape changing section 70 between firstbone segment 10 and second bone segment 20 that can deform to becomesection 80 and pull so the fragments together so as to close the bonygap 60 and hold the bone healing interfaces 62 and 64 in contact. Theactivator is not shown in FIGS. 3-4 .

FIGS. 5-6 are illustrative of a shape changing bone staple. Such shapechanging bone staple does not include an activator. FIG. 5 illustrates ashape changing bone staple 100 with the bridge extended, legsstraightened and mechanically unstable so that its spontaneous shapechange can close the gap 60. FIG. 6 illustrates the shape changing bonestaple 100 of FIG. 5 with the bridge contracted and legs deflectedinward to hold the gap 50 closed and compress the bone segments 10 and20. The contracted shape changing bone staple 100 of FIG. 5 is shapechanging bone staple 110 of FIG. 6 .

Accordingly, the shape changing staple 100 (in its uncontracted state)can shorten its bridge and swings its legs inward its contract to closethe gap 60 and hold the healing interface 50 in contact. The shapechanging bridge and legs of staple 100 act together to pull together andcompress the bone segments to avoid bone gaping and strain the healingbone.

Shape Changing Cage (with Internal Spring)

FIGS. 7-12 are illustrative of a shape changing cage used to pulltogether and compress bone segments. This is an example of a bonehealing implant that can be positioned by the clinician while theimplant does not apply mechanical force to compress the bone segments(to be healed) and, after positioning, the bone healing implant can bemechanically activated to apply the compressive mechanical force.

FIG. 7 illustrates a shape changing cylindrical fenestrated hollow cage120, in its extended length, contracted diameter and unstable state,which uses an internal spring to close the gap 60 and compress the boneinterfaces 62 and 64.

FIG. 8 illustrates the shape changing cylindrical fenestrated hollowcage 120 of FIG. 7 in its contracted length and expanded diameter (shapechanging cylindrical fenestrated hollow cage 130) using an internalspring's strain energy to expand the cage diameter, lock into thecentral lumen of bone and shorten the length of cage shape changingcylindrical fenestrated hollow cage 130 (as compared to shape changingcylindrical fenestrated hollow cage 120) so as to closed and compressthe gap 50 between bone segments 10 and 20.

FIG. 9 illustrates an orthogonal view of the bone fixation cylindricalcage 120 of FIG. 7 with lock pin 250 in its elongated and diametricallycontracted pre-implantation condition with maximum stored mechanicalstrain energy. Lock pin 250 includes lock pin manipulator 260. FIG. 9further shows the movable connected expansion members 190 and thecircular fenestrations 200 (for bone growth) of bone fixationcylindrical cage 120.

FIG. 10 illustrates an orthogonal view of the bone fixation cylindricalcage 130 of FIG. 8 in its shortened and expanded post-implantationcondition with no stored mechanical strain energy. (When utilized, thebone fixation cylindrical cage does not fully shorten, so some of thestored mechanical strain energy remains to maintain compression.) FIG.10 shows the movable connected expansion members 190 (after movement)and the circular fenestrations 200 of bone fixation cylindrical cage130. FIG. 10 also shows elongated fenestrations for bone growth 210 andlock pin receiver 270.

FIG. 11 illustrates a plane view of the bone fixation cylindrical cage130 of FIG. 8 in its shortened and expanded post-implantation conditionwith no stored mechanical strain energy showing bone locking members190, bone in growth fenestrations 210, circular fenestrations 200, andlock pin receiver 270.

FIG. 12 illustrates an orthogonal view of the components of the bonefixation cylindrical cage of FIGS. 7-8 that disassembled to show its twocylindrical components 280 and 290 and spring 220. FIG. 12 also showsthe movably connected expansion member actuator 230 and the shapechanging cylindrical internal locking fenestration 240.

During use, the shape changing cylindrical fenestrated hollow cage 120is inserted in its extended length and contracted diameter. Onceproperly positioned by the clinician, the shape changing cage 120 isactivated so that it takes on a shortened and diametrically expandedconfiguration of shape changing cage 130. In the illustrated embodiment,activation is accomplished by pulling the mechanism lock pin 250 by itsmanipulator 260 to remove it from the shape changing cage. Onceactivated the spring 220 elongates to pull together the cage components280 and 290. As the cage components over slide one another the lockingmember actuators 230 push out on the expansion member 190 to lock intothe lumen of bone and pull the two bone segments 10 and 20 together andhold and compress their healing interface. The cage's fenestrations andlumens act to conduct bone to form within the lumen and across thehealing site.

It should be noted that in this design, the lock pin 250 is utilized tokeep the shape changing cylindrical fenestrated hollow cage 120 in itsextended length and, once the lock pin 250 is withdrawn the spring 220acts on the shape changing cylindrical fenestrated hollow cage 120 totransition to the shortened and diametrically expanded configuration ofshape changing cage 130 due to mechanical properties of the spring 220and cage materials used.

For example, the materials used in fabricating the shape changing cage120 can include nitinol, and the spring 220 maintains nitinol in theshape changing cage 120 in the form of stress induced or stress retainedmartensite. When the spring 220 is released, some or all of the nitinolin the form of martensite changes in form to the form of austenite.Stress induced martensite is created when nitinol in its austeniticcrystalline structure is strained. Stress retained martensite is createdby cooling austenitic nitinol below its martensitic finish temperature,manipulating the device to a second shape and then mechanicallystraining the device into this second shape and restraining it with amechanical activator so that at higher temperatures its martensiticstructure is retained until the implant is activated. Alternatively, thematerials used in shape changing cage 120 can include a different shapememory metal or can include only metal that is not a shape memory metal.With respect to the later, the shape changing cage 120 would be held ina different shape without exceeding the elastic deformation limits ofthe metal utilized.

In such embodiments described above, the spring 220 is exerting effortto extend and is not used to apply compressive forces. In otherembodiments, a spring can be used to provide compressive forces;however, such design is viewed as being less stable (and lessadvantageous) because the tension in the spring can be compromised overtime.

Shape Changing Cage (without Internal Spring)

FIGS. 13-18 are illustrative of a shape changing cage used to pulltogether and compress bone segments. This is another example of a bonehealing implant that can be positioned by the clinician while theimplant does not apply mechanical force to compress the bone segments(to be healed) and, after positioning, the bone healing implant can bemechanically activated to apply the compressive mechanical force. Unlikethe shape changing cage of FIGS. 7-12 , this shape changing cage doesnot utilize an internal spring.

FIG. 13 illustrates a shape changing cylindrical fenestrated hollow cage140 in its extended length, contracted diameter and unstable state thatuses its elastic material properties to close the gap 60 and compressingthe bone interfaces 62 and 64.

FIG. 14 illustrates the shape changing cylindrical fenestrated hollowcylinder 140 of FIG. 13 in its contracted length and expanded diameter(shape cylindrical fenestrated hollow cylinder 150) using its materialproperties to pull the gap 50 closed and compress the bone interfaces 62and 64.

FIG. 15 illustrates the orthogonal view of a bone fixation cylindricalcage 140 of FIG. 13 in its elongated and diametrically contractedpre-implantation condition with bone ingrowth fenestrations 520 andholes 510, and elongated ribs 570 storing maximum mechanical strainenergy. FIG. 15 further shows instrument driving fenestrations 540,instrument release fenestrations 550, and shape changing bone fixationcylinder lumen 560 (for bone ingrowth).

FIG. 16 illustrates the orthogonal view of a bone fixation cylindricalcage 150 of FIG. 14 in its shortened and expanded post-implantationcondition with bulging ribs 530 and no stored mechanical strain energy.

FIG. 17 illustrates the orthogonal view of the bone fixation cylindricalcage 140 of FIG. 13 in its extended and diametrically contractedpre-implantation state while locked on the implantation mandrel 153having a bone cutting insertion tip 156, with the mandrel lobe 155engaged in cage instrument fenestration 550 and the driver fenestrations540 accessible to facilitate release. (The mandrel lobe 155 is shown inFIG. 18 ).

FIG. 18 illustrates an orthogonal view of the bone fixation cylindricalcage 150 in its shortened and expanded post-implantation configurationfollowing release from the implantation mandrel 153 through release ofthe mandrel lobe 155 and cage instrument release fenestration 550.

During use, the shape changing cage 140 is inserted while in itsextended length and contracted diameter by the use of the insertionmandrel 153. The mandrel 153 is sharp with a cutting tip 156 on one endand is advanced into bone while turning. Once inserted in bone, theshape changing cage 140 is released and takes on a shortened anddiametrically expanded configuration (of shape changing cage 150). Torelease, the cage 140 and mandrel 153 are counter rotated so as tounlock the cage 140 from the mandrel 153. The diameter expansion locksthe cage into bone, the shortening brings the bones together andcompresses, the fenestrations and lumen conduct bone through the cageand across the healing interface.

Shape Changing Washer and Bone Screw System

FIGS. 19-25 are illustrative of a shape changing washer and bone screwsystem used to pull together and compress bone segments. This is anexample of a bone healing implant in which compressive mechanical forceis applied while the implant is being positioned by the clinician. Thisembodiment is unique in that it uses elastic and pseudo-elasticdeformation of the shape changing washer to implement and maintain thecompressive forces.

FIG. 19 illustrates a shape changing washer 170 it its unstable statethat, using the material's elastic properties, pulls on a bone screw 160to pull together bone segments 10 and 20 to close the gap 60.

FIG. 20 illustrates the shape changing washer 170 of FIG. 19 that, usingthe material's elastic properties, deflects its structure (shapechanging washer 180) to pull on the bone screw 160 to pull together bonesegments 10 and 20, hold the gap 50 closed, and compress the bonesegments 10 and 20 at the healing interface.

FIGS. 21-23 illustrate the shape changing of the shape changing washer170 as it is utilized with threaded bone screw 160. FIG. 21 illustratesthreaded bone screw 160 with mechanical energy storing shape changingwasher 170 fully strained and storing maximum energy. FIG. 22illustrates the threaded bone screw 160 and mechanical energy storingshape changing washer 170 of FIG. 21 partially strained (mechanicalenergy storing shape changing washer 180) and storing an intermediateamount of energy. FIG. 23 illustrates the threaded bone screw 160 andmechanical energy storing shape changing washer 170 of FIG. 21 fullyrecovered in its shape (mechanical energy storing shape changing washer185) and storing no energy.

FIGS. 24-25 illustrate orthogonal views of an alternate embodiment of ashape changing washer 400 that can be used with a threaded bone screw(such as threaded bone screw 160 shown in FIGS. 21-23 ). In FIG. 24 ,shape changing washer 400 is shown fully recovered in its shape changingbellows section 420 and storing no energy. In FIG. 25 , shape changingwasher 400 is shown fully extended in its shape changing bellows section410 and storing maximum energy.

During use, the shape changing washer 170 converts its elasticmechanical energy to pull the screw 160 by deflecting to a second shape(shape changing washer 180). The shape changing washer 185 (having nostored elastic energy) is on screw 160. As the screw 160 is threadedinto bone, the shape changing washer 185 is strained and conforms to thescrew 160 and takes on the strained shape (shape changing washer 170).If a gap forms, the shape changing washer 170 transitions to thepartially deflected stated (shape changing washer 180) and pulls thescrew 160 to hold the gap 60 closed so that the interface 50 is inconstant contact and compressed.

In an alternate embodiment (shown in FIGS. 24-25 ), shape changingwasher 400 has a bellows section that elongates and contracts to pullthe bone screw 160. Fenestrations can be placed in the walls of thewasher 400 to facilitate bone ingrowth and retention.

CONCLUSIONS AND SCOPE

The embodiments illustrated in this application are a significantadvancement over the prior art rigid bone fixation implants in light of:(1) the simultaneous method of fixating bone and promoting healing, (2)the method of pulling together healing bone segments to that a gap doesnot form, (3) the method of minimizing non-healing due to fibrous tissueinfiltration by blocking infiltration by not allowing a gap to form, (4)the method of stimulating bone cells and matrix by mechanicalcompression, (5) the method of stimulating bone healing throughdeformation of the hydroxyapitite calcium phosphate bone crystals tocreate current flow and bone cell recruitment to the healing wound, (6)the method of bone ingrowth and conduction through the implant andacross the healing interface and (7) the incorporation of shape changingfeatures into implants including but not limited to screws, washers,cylinders, plates, staples, rods, and external fixation devices.

Although the description above contains many specificities, these shouldnot be construed as limiting the scope of the embodiments but as merelyproviding illustrations of some of the presently preferred embodiments.Thus the scope of the embodiment should be determined by the appendedclaims and their legal equivalents, rather than by the examples given.

The disclosures of all patents, patent applications, and publicationscited herein are hereby incorporated herein by reference in theirentirety, to the extent that they provide exemplary, procedural, orother details supplementary to those set forth herein.

REFERENCES

References in the field of the present invention include:

-   U.S. Pat. No. 5,882,351 (Fox) (“Fox '351 Patent”).-   U.S. Pat. No. 6,287,310 (Fox) (“Fox '310 Patent”).-   U.S. Pat. No. 7,240,677 (Fox) (“Fox '677 Patent”).-   U.S. Patent Appl. Serial No. 2008/0161808 (Fox) (“Fox '808    Application”).-   U.S. Patent Appl. Serial No. 2010/0063506 (Fox) (“Fox '506    Application”).-   U.S. Pat. No. 6,059,787 (Allen) (“Allen '787 Patent”).-   U.S. Pat. No. 6,348,054 (Allen) (“Allen '054 Patent”).-   U.S. Pat. No. 6,783,531 (Allen) (“Allen '531 Patent”).-   U.S. Pat. No. 5,779,707 (Bertolet) (“Bertolet '707 Patent”).-   U.S. Pat. No. 6,325,805 (Flot) (“Flot '805 Patent”).-   U.S. Pat. No. 6,323,461 (Flot) (“Flot '461 Patent”).-   U.S. Pat. No. 5,449,359 (Groiso) (“Groiso '359 Patent”).-   U.S. Pat. No. 5,853,414 (Groiso) (“Groiso '414 Patent”).-   U.S. Pat. No. 7,635,367 (Groiso) (“Groiso '367 Patent”).-   U.S. Pat. No. 5,067,957 (Jervis) (“Jervis '957 Patent”).-   U.S. Pat. No. 5,246,443 (Mai) (“Mai '443 Patent”).-   U.S. Pat. No. 5,474,557 (Mai) (“Mai '557 Patent”).-   U.S. Pat. No. 3,939,828 (Mohr) (“Mohr '828 Patent”).-   U.S. Pat. No. 6,325,805 (Ogilvie) (“Ogilvie '805 Patent”).-   U.S. Patent Appl. Serial No. 2007/0162026 (Tipirneni) (“Tipirneni    '026 Application”).-   U.S. Patent Appl. Serial No. 2007/0260248 (Tipirneni) (“Tipirneni    '248 Application”).-   U.S. Patent Appl. Serial No. 2008/0147127 (Tipirneni) (“Tipirneni    '127 Application”).-   Chamay, A, Tschantz, P, “Mechanical Influences in Bone Remodeling.    Experimental Research on Wolff's Law,” J. Biomechanics, 1972,    5:173-180 (“Chama 1972”).-   Chao, E Y S, Inoue, N, “Biophysical Stimulation of Bone Fracture    Repair, Regeneration and Remodelling,” European Cells and Materials,    2003, 6:72-85 (“Chao 2003”).-   Robling, A G, Castillo, A B, Turner, C H, “Biomechanical and    Molecular Regulation of Bone Remodeling,” Annu. Rev. Biomed. Eng.,    2006, 8:455-498 (“Robling 2006”).-   Rubin, C T, Lanyon, L E “Regulation of Bone Mass by Mechanical    Strain Magnitude,” Calcif. Tissue Int., 1985, 37:411-417 (“Rubin    1985”).-   Turner, C H, Burr D B, “Basic Biomechanical Measurements of Bone: A    Tutorial,” Bone, 1993, 14:595-608 (“Turner 1993”).-   Warden, S J, Turner, C H, “Mechanotransduction in cortical bone is    most efficient at loading frequencies of 5-10 hz,” Bone, 2004,    34:261-270 (“Warden 2004”).-   Product Sell Sheet [online], BioMedical Enterprises, Inc., 2012 (San    Antonio, Tex.) [retrieved on 2012-10-04] (“BioMedical Enterprises's    Product Sell Sheet”). Retrieved from the Internet <URL:    www.bme-tx.com/resources/details/category/product-sell-sheets>.-   OSStaple Brochure, BioMedical Enterprises, Inc., A108-076 (Rev B),    2010.-   Memory Staple Brochure, Biopro, Inc. (Port Huron, Mich.), Brochure    No. 17704, rev 2 (“Biopro's Memory Staple Brochure”).-   Memory Staple Brochure, Depuy Inc., 0612-00-584 (Rev. 1), 2006    (“Depuy's Memory Staple Brochure”).-   Easy Clip SI Brochure, MemoMetal Inc. USA (Memphis, Tenn.),    ECLP10000—rev. D, 2009.-   Charlotte Foot and Ankle Fixation System, Wright Medical Technology,    Inc. (Arlington, Tenn.) 50 040-105-Rev. Apr. 6, 2005.-   FDA Clearance To Market Letter K080649, for Pogo® screw of FxDevices    (Boca Raton, Fla.), dated Nov. 25, 2008 (“FDA K080649 Clearance to    Market Letter”).

What is claimed is:
 1. A bone healing method comprising the steps of:(a) selecting a bone implant operable for pulling together a first bonesegment and a second bone segment and operable for compressing the firstbone segment and the second bone segment at a bone healing interface;(b) positioning the bone implant in a position to pull the first bonesegment and the second bone segment together and to compress the firstbone segment and the second bone segment at the bone healing interface,wherein (i) during the step of positioning, the bone implant is lockedin a first shape, (ii) during the step of positioning, the bone implantapplies no mechanical force to pull the first bone segment and thesecond bone segment together, and (iii) during the step of positioning,the bone implant applies no mechanical force to compress the first bonesegment and the second bone segment at the bone healing interface; and(c) after positioning of the bone implant, mechanically activating thebone implant by unlocking the bone implant and releasing the boneimplant from the first shape to a second shape that is different fromthe first shape, wherein (i) the mechanically activated bone implantpulls together the first segment and the second bone segment, (ii) themechanically activated bone implant compresses the first bone segmentand the second bone segment at the bone healing interface, and (iii) themechanically activated bone implant maintains the first bone segment andthe second bone segment at the bone healing interface while the firstbone segment and the second bone segment heal.
 2. The bone healingmethod of claim 1, wherein the bone implant is selected from the groupconsisting of cages, wires, staples, plates, screws, rods, tubularstructures, external fixation devices, and combinations thereof.
 3. Thebone healing method of claim 1, wherein the first shape is an expandedshape.
 4. The bone healing method of claim 3, wherein the second shapeis a contracted shape.
 5. The bone healing method of claim 1, whereinchange of the bone implant from the first shape to the second shapecomprises a first shape change in a first direction and a second shapechange in another direction, wherein (a) the first shape change and thesecond shape change are different; (b) the first shape change is a shapeexpansion or contraction; and (c) the second shape change is a shapeexpansion or contraction.
 6. The bone healing method of claim 1, whereinthe change of the bone implant to the second shape is operable for (a)pulling together the first bone segment and the second bone segment, and(b) compressing the first bone segment and the second bone segment atthe bone healing interface.
 7. The bone healing method of claim 1,wherein the bone implant comprises nitinol.
 8. The bone healing methodof claim 7, wherein the bone implant comprises an activator, wherein (a)before the activator is removed from the bone implant, the activatorretains the bone implant locked in the first shape in which at leastsome of the nitinol in the bone implant is in the form of stress inducedor retained martensite, (b) the activator is removed from the boneimplant during the step of mechanically activating the bone implant, and(c) after the activator is removed from the bone implant, the boneimplant changes shape, wherein at least some of the nitinol in the boneimplant changes in form to austenite.
 9. The bone healing method ofclaim 1, wherein the bone healing implant comprise a material selectedfrom the group consisting of shape memory metals, elastic biocompatiblemetals, elastic biocompatible polymers, and combinations thereof. 10.The bone healing method of claim 1, wherein the bone healing implantcomprises a material selected from the group consisting of stainlesssteel, titanium, and combinations thereof.
 11. The bone healing methodof claim 1, wherein the bone healing implant comprises a materialselected from the group consisting of polyether ether ketone (PEEK),polyethylene, and combinations thereof.
 12. The bone healing method ofclaim 1, wherein (a) the bone implant comprises nitinol, and (b) beforethe mechanically activating the bone implant, the bone implant is in theform of martensite.
 13. The bone healing method of claim 1, wherein thebone implant holds together the first bone segment and the second bonesegment such that soft tissue infiltration is blocked.
 14. The bonehealing method of claim 1, wherein the bone implant deforms the firstbone segment and the second bone segment so as to create an electricalcurrent flow in the first bone segment and the second bone segment. 15.The bone healing method of claim 1, wherein the bone implant comprises ashape changing cage.
 16. The bone healing method of claim 15, whereinthe shape changing cage comprises at least one bone conducting scaffoldfeature.
 17. The bone healing method of claim 15, wherein the shapechanging cage comprises a first component and a second component. 18.The bone method of claim 17, wherein during the step of mechanicalactivation: (a) a locking pin is removed from the bone implant; and (b)the first component and the second component are pulled together,wherein the pulling together of the first component and the secondcomponent (i) pulls together the first bone segment and the second bonesegment, (ii) compresses the first bone segment and the second bonesegment at the bone healing interface, and (iii) maintains the firstbone segment and the second bone segment at the bone healing interfacewhile the first bone segment and the second bone segment heal.
 19. Thebone healing method of claim 18, wherein the shape changing cagecomprises nitinol.
 20. The bone healing method of claim 18, wherein theshape changing cage comprises a material selected from the groupconsisting of shape memory metals, elastic biocompatible metals, elasticbiocompatible polymers, and combinations thereof.
 21. The bone healingmethod of claim 18, wherein the shape changing cage comprises a materialselected from the group consisting of stainless steel, titanium, andcombinations thereof.
 22. The bone healing method of claim 18, whereinthe shape changing cage comprises a material selected from the groupconsisting of polyether ether ketone (PEEK), polyethelene, andcombinations thereof.
 23. The bone healing method of claim 15, whereinthe shape changing cage comprises: (a) a first cylindrical component;and (b) a second cylindrical component, wherein the first cylindricalcomponent and second cylindrical component are locked in place toprevent them from moving together.
 24. The bone method of claim 15,wherein the bone implant further comprises a mandrel that locks theshape changing cage in ft the first shape.
 25. The bone healing methodof claim 24, wherein the mandrel comprises a bone cutting insertion tipthat is used during the step of positioning the bone implant.
 26. Themethod of claim 24, wherein the step of mechanically activating the boneimplant comprises unlocking the cage by removing the mandrel from theimplant, wherein (a) unlocking the cage allows the cage to change itsshape; and (b) the change in shape of the cage (i) pulls together thefirst segment and the second bone segment, (ii) compresses the firstbone segment and the second bone segment at the bone healing interface,and (iii) maintains the first bone segment and the second bone segmentat the bone healing interface while the first bone segment and thesecond bone segment heal.
 27. The bone healing method of claim 24,wherein the shape changing cage comprises nitinol.
 28. The bone healingmethod of claim 24, wherein the shape changing cage comprises a materialselected from the group consisting of shape memory metals, elasticbiocompatible metals, elastic biocompatible polymers, and combinationsthereof.
 29. The bone healing method of claim 24, wherein the shapechanging cage comprises a material selected from the group consisting ofstainless steel, titanium, and combinations thereof.
 30. The bonehealing method of claim 24, wherein the shape changing cage comprises amaterial selected from the group consisting of polyether ether ketone(PEEK), polyethylene, and combinations thereof.
 31. A bone healingmethod comprising the steps of: (a) selecting a bone implant, whereinthe bone implant comprises at least one bone scaffold feature; (b)positioning the bone implant in a position to pull a first bone segmentand a second bone segment together and to compress the first bonesegment and the second bone segment at a bone healing interface,wherein, during the step of positioning (i) the bone implant is lockedin a first shape, (ii) the bone implant applies no mechanical force topull the first bone segment and the second bone segment together, and(iii) the bone implant applies no mechanical force to compress the firstbone segment and the second bone segment at the bone healing interface;and (c) after the bone implant is positioned, mechanically activatingthe bone implant by unlocking the bone implant and releasing the boneimplant from the first shape to a second shape that is different fromthe first shape, wherein (i) the bone implant pulls together the firstbone segment and the second bone segment, (i) the bone implantcompresses the first bone segment and the second bone segment at thebone healing interface, and (ii) the bone implant maintains the firstbone segment and the second bone segment at the bone healing interfacewhile the first bone segment and the second bone segment heal, whereinthe bone scaffold feature conducts bone through the bone implant andacross the healing bone interface while the first bone segment and thesecond bone segment heal.